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Non-invasive Quantification of Liver Iron With MRI

Primary Purpose

Iron Overload

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

GE Optima/Discovery® MRI data of the liver

About this trial

This is an interventional diagnostic trial for Iron Overload

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Be at least ten (10) years of age;
Have clinical history of iron overload;
If female of childbearing potential (not surgically sterile or post-menopausal), be determined non-pregnant by the medical co-investigator and/or a delegated physician on the study staff or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before participating in study procedures;
Provide evidence of willingness to participate by providing written informed consent to participate OR, if aged less than 18 years (<18) be willing to provide written assent to participate and have parent(s) or legal guardian(s) willing to provide written informed consent for the subject's participation;
Be able to hear and understand instructions without assistive devices;
Have necessary mental capacity to understand instructions be able to comply with protocol requirements;
Be able to remain relatively motionless for the expected duration of imaging procedures (maximum of approximately 90 minutes).

Exclusion Criteria

Have medical history of present or prior focal liver disease, such as neoplasms or vascular abnormalities;
Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site;
Are scheduled for surgery, changes in dosage or type of chelating medications, or other medical interventions in between blood draw and MRI scanning that could be expected to impact study results or conduct;
Have had or plan to have a change in dosage or type of chelating medications (such as Deferoxamine or Deferasirox) within the 3 days prior to the first study procedure (blood draw or MRI, whichever comes first);
Are minor subjects with parent(s) or legal guardian(s) that require that they accompany the subject into the MR environment;
Have previously participated in this study.

Sites / Locations

University of Wisconsin-Madison

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI imaging of liver

Arm Description

GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®

Outcomes

Primary Outcome Measures

Per Subject Evaluable DICOM Data Sets From Liver MRI

The primary outcome measure is collection of evaluable (based on physician determination) MR DICOM datasets including valid 1.5 and 3.0T image data, P-file, R2* maps, and raw data for each enrolled subject. The datasets were gathered via three independent MR scans conducted within a three hour time block, with up to ten minutes break in between.

Secondary Outcome Measures

Serum Ferritin Based on Blood Draw

The secondary outcome is collection of serum ferritin from hematologic analysis (blood draw analyzed by site central lab).

Full Information

NCT ID

NCT02425956

First Posted

March 16, 2015

Last Updated

June 22, 2017

Sponsor

GE Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT02425956

Brief Title

Non-invasive Quantification of Liver Iron With MRI

Official Title

Non-invasive Quantification of Liver Iron With MRI

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

June 30, 2016 (Actual)

Study Completion Date

June 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GE Healthcare

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

This study is being conducted to build a library of prospectively collected clinical data from subjects with iron overload examined with commercially available MRI devices. This data library is intended for use in future engineering development and other research activities, including future regulatory submissions. Data from human subjects is required to develop and test Magnetic resonance (MR) reconstruction techniques that can provide quantitative information about tissue properties, such as volumetric fat and iron concentrations. Collection of MR data and corresponding quantitative liver iron concentration (LIC) data is necessary for development of MR techniques that can show both overall and regional iron concentrations of in vivo tissues. These techniques may provide viable alternatives to invasive and expensive conventional liver biopsy and to less accurate serum biomarker testing, potentially benefiting future clinical patients with iron overload. MR image data and corresponding quantitative data about serum and liver iron levels will be collected from each subject in this study. These datasets are considered suitable for future development and testing of MR reconstruction software, including MR reconstruction algorithms developed by General Electric Healthcare (GEHC) to use Longitudinal relaxation rate equal to the reciprocal of T2 relaxation time (1/T2) (R2) techniques to assess LIC. To achieve a sufficiently diverse library for future testing, MRI data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GEHC IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan® Specialized Reconstruction Service guidelines (Resonance Health, Claremont, AU). Quantitative hematologic (serum ferritin) based on blood testing and FerriScan® Analysis Service LIC reports will be collected for each subject.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Overload

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MRI imaging of liver

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

GE Optima/Discovery® MRI data of the liver

Other Intervention Name(s)

GE Optima/Discovery® MRI, FerriScan® (Resondence Health), GE IDEAL IQ®

Intervention Description

GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer

Primary Outcome Measure Information:

Title

Per Subject Evaluable DICOM Data Sets From Liver MRI

Description

Time Frame

48 hours pre or 24 hours post blood draw

Secondary Outcome Measure Information:

Title

Serum Ferritin Based on Blood Draw

Description

The secondary outcome is collection of serum ferritin from hematologic analysis (blood draw analyzed by site central lab).

Time Frame

48 hours post MR scan or 24 hours pre MR scan

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Be at least ten (10) years of age; Have clinical history of iron overload; If female of childbearing potential (not surgically sterile or post-menopausal), be determined non-pregnant by the medical co-investigator and/or a delegated physician on the study staff or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before participating in study procedures; Provide evidence of willingness to participate by providing written informed consent to participate OR, if aged less than 18 years (<18) be willing to provide written assent to participate and have parent(s) or legal guardian(s) willing to provide written informed consent for the subject's participation; Be able to hear and understand instructions without assistive devices; Have necessary mental capacity to understand instructions be able to comply with protocol requirements; Be able to remain relatively motionless for the expected duration of imaging procedures (maximum of approximately 90 minutes). Exclusion Criteria Have medical history of present or prior focal liver disease, such as neoplasms or vascular abnormalities; Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site; Are scheduled for surgery, changes in dosage or type of chelating medications, or other medical interventions in between blood draw and MRI scanning that could be expected to impact study results or conduct; Have had or plan to have a change in dosage or type of chelating medications (such as Deferoxamine or Deferasirox) within the 3 days prior to the first study procedure (blood draw or MRI, whichever comes first); Are minor subjects with parent(s) or legal guardian(s) that require that they accompany the subject into the MR environment; Have previously participated in this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank Korosec, PhD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin-Madison

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Non-invasive Quantification of Liver Iron With MRI

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